The Recall Desk

FDA (Devices) recall action 86312

OraSure Technologies, Inc. recalled 3 products on 2020-09-30

The FDA (Devices) publishes a recall like this one as 3 separate product records. They share a firm, a date and a cause; this page is all of them in one place, so the scale of the action is visible rather than spread across 3 pages.

Products
3
Announced
2020-09-30
Critical
0
Units
49,620

Why these products were recalled

Unit boxes not properly sealed

The agency’s own wording, quoted from the enforcement report.

The unit total adds up the quantities the agency stated for each product. Where a product record gave no figure, or gave a weight rather than a count, it contributes nothing — so the real total is at least this, never less.

States named across these recalls

1–3 of 3

  • LowFDA (Devices)··2020-09-30

    OraSure CVS Advanced Wart Remover Kit Recalled for Improper Sealing

    OraSure Technologies is recalling CVS Advanced Wart Remover Kits because unit boxes were not properly sealed. The recall covers 23,400 units distributed in the US, Canada, and Brazil.

    Product
    CVS Advanced Wart Remover Kit, Catalog Number: 1001-0407 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of common warts and plantar warts.
    Category
    Distribution
    2 states
  • LowFDA (Devices)··2020-09-30

    OraSure Pointts Skin Tag Removal System Recalled for Unsealed Boxes

    OraSure Technologies is recalling Pointts skin tag removal systems because unit boxes were not properly sealed. The recall affects 23,220 units distributed in the US, Canada, and Brazil.

    Product
    Pointts sistema de ellmlnact!;o de verrugas OTC - Brazil Catalog Number: 1001-0280 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of skin tags.
    Category
    Distribution
    2 states
  • LowFDA (Devices)··2020-09-30

    OraSure Personelle OTC Skin Tag Remover Recalled for Improperly Sealed Boxes

    OraSure Technologies is recalling 3,000 units of Personelle OTC Skin Tag Remover because unit boxes were not properly sealed.

    Product
    Personelle OTC Skin Tag Remover, Canada Catalog Number: 1001-0314 - Product Usage: indicated for over-the-counter a cryosurgical system for the treatment of skin tags.
    Category
    Distribution
    2 states